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Document 52007XC0629(01)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
OJ C 144, 29.6.2007, p. 5–10
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.6.2007 |
EN |
Official Journal of the European Union |
C 144/5 |
Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 May 2007 to 31 May 2007
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2007/C 144/06)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|||||
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2.5.2007 |
Focetria |
A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen |
|
EU/1/07/385/001-004 |
Suspension for injection |
J07BB02 |
4.5.2007 |
|||||
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21.5.2007 |
ORENCIA |
abatacept |
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EU/1/07/389/001-003 |
Powder for concentrate for solution for infusion |
L04AA24 |
23.5.2007 |
|||||
|
24.5.2007 |
Altargo |
retapamulin |
|
EU/1/07/390/001-004 |
Ointment |
D06AX13 |
29.5.2007 |
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
|||||
|
22.5.2007 |
Mycograb |
|
— |
29.5.2007 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||||||
|
2.5.2007 |
Aranesp |
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EU/1/01/185/001-073 |
4.5.2007 |
||||||
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2.5.2007 |
Liprolog |
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EU/1/01/195/001-015 |
4.5.2007 |
||||||
|
2.5.2007 |
BeneFIX |
|
EU/1/97/047/001-003 |
4.5.2007 |
||||||
|
2.5.2007 |
Vfend |
|
EU/1/02/212/001-026 |
4.5.2007 |
||||||
|
2.5.2007 |
Nespo |
|
EU/1/01/184/001-073 |
4.5.2007 |
||||||
|
2.5.2007 |
Invirase |
|
EU/1/96/026/001-002 |
4.5.2007 |
||||||
|
2.5.2007 |
Norvir |
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EU/1/96/016/001 EU/1/96/016/003-004 |
4.5.2007 |
||||||
|
2.5.2007 |
Viramune |
|
EU/1/97/055/001-003 |
4.5.2007 |
||||||
|
2.5.2007 |
Viread |
|
EU/1/01/200/001 |
4.5.2007 |
||||||
|
2.5.2007 |
Osigraft |
|
EU/1/01/179/001 |
4.5.2007 |
||||||
|
2.5.2007 |
Sustiva |
|
EU/1/99/110/001-009 |
4.5.2007 |
||||||
|
2.5.2007 |
Stocrin |
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EU/1/99/111/001-011 |
4.5.2007 |
||||||
|
3.5.2007 |
Protopy |
|
EU/1/02/202/001-006 |
7.5.2007 |
||||||
|
3.5.2007 |
Crixivan |
|
EU/1/96/024/001-005 EU/1/96/024/007-008 EU/1/96/024/010 |
8.5.2007 |
||||||
|
3.5.2007 |
Protopic |
|
EU/1/02/201/001-006 |
7.5.2007 |
||||||
|
3.5.2007 |
Infanrix Hexa |
|
EU/1/00/152/001-018 |
7.5.2007 |
||||||
|
3.5.2007 |
Infanrix Penta |
|
EU/1/00/153/001-010 |
7.5.2007 |
||||||
|
3.5.2007 |
Humalog |
|
EU/1/96/007/002 EU/1/96/007/004-006 EU/1/96/007/008 EU/1/96/007/010-011 EU/1/96/007/015-021 EU/1/96/007/023-030 |
7.5.2007 |
||||||
|
11.5.2007 |
Prialt |
|
EU/1/04/302/001-004 |
15.5.2007 |
||||||
|
14.5.2007 |
PritorPlus |
|
EU/1/02/215/001-014 |
16.5.2007 |
||||||
|
14.5.2007 |
Hepsera |
|
EU/1/03/251/001-002 |
16.5.2007 |
||||||
|
14.5.2007 |
Humira |
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EU/1/03/256/001-010 |
16.5.2007 |
||||||
|
14.5.2007 |
Trudexa |
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EU/1/03/257/001-010 |
16.5.2007 |
||||||
|
15.5.2007 |
Omnitrope |
|
EU/1/06/332/001-006 |
18.5.2007 |
||||||
|
15.5.2007 |
Iscover |
|
EU/1/98/070/001a–006a EU/1/98/070/001b-006b |
17.5.2007 |
||||||
|
15.5.2007 |
Plavix |
|
EU/1/98/069/001a-006a EU/1/98/069/001b-006b |
21.5.2007 |
||||||
|
15.5.2007 |
Xagrid |
|
EU/1/04/295/001 |
17.5.2007 |
||||||
|
22.5.2007 |
Thelin |
|
EU/1/06/353/001-005 |
25.5.2007 |
||||||
|
22.5.2007 |
Zavesca |
|
EU/1/02/238/001 |
25.5.2007 |
||||||
|
22.5.2007 |
Teslascan |
|
EU/1/97/040/001-002 |
25.5.2007 |
||||||
|
22.5.2007 |
Opatanol |
|
EU/1/02/217/001-002 |
24.5.2007 |
||||||
|
30.5.2007 |
Xolair |
|
EU/1/05/319/001-004 |
1.6.2007 |
||||||
|
30.5.2007 |
Caelyx |
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EU/1/96/011/001-004 |
1.6.2007 |
||||||
|
30.5.2007 |
Ventavis |
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EU/1/03/255/001-005 |
1.6.2007 |
||||||
|
30.5.2007 |
Remicade |
|
EU/1/99/116/001-003 |
1.6.2007 |
||||||
|
30.5.2007 |
LeukoScan |
|
EU/1/97/032/001 |
1.6.2007 |
||||||
|
30.5.2007 |
Ziagen |
|
EU/1/99/112/001-002 |
1.6.2007 |
||||||
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30.5.2007 |
Kivexa |
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EU/1/04/298/001-002 |
1.6.2007 |
||||||
|
30.5.2007 |
AVANDIA |
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EU/1/00/137/002-018 |
1.6.2007 |
||||||
|
30.5.2007 |
Viramune |
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EU/1/97/055/001-003 |
1.6.2007 |
||||||
|
30.5.2007 |
Avaglim |
|
EU/1/06/349/001-010 |
1.6.2007 |
||||||
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31.5.2007 |
Ketek |
|
EU/1/01/191/001-005 |
4.6.2007 |
||||||
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31.5.2007 |
Levviax |
|
EU/1/01/192/001-005 |
5.6.2007 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
|
14.5.2007 |
Nobilis Influenza H7N1 |
Inactivated whole avian influenza virus antigen of H7N1 subtype (strain, A/CK/Italy/473/99), inducing an HI titre of ≥ 6,0 log2 as tested according to the potency test. |
Intervet International B.V. |
EU/2/07/073/001-004 |
Emulsion for injection |
QI01AA23 |
16.5.2007 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
|
Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
||
|
15.5.2007 |
METACAM |
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EU/2/97/004/007-008 EU/2/97/004/014-015 EU/2/97/004/027-028 |
18.5.2007 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
|
The European Medicines Agency |
|
7, Westferry Circus |
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Canary Wharf |
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London E14 4HB |
|
United Kingdom |
(1) OJ L 136 of 30 April 2004, page 1